Role Summary
Executive Medical Director - Cardio-Renal. Lead clinical development for Lillyβs cardio-renal portfolio, providing strategic direction, trial leadership, and cross-functional collaboration to advance molecules from preclinical to clinical development and potential commercialization.
Responsibilities
- Provide clinical development leadership across all phases for cardio-renal programs, including heart failure, ASCVD, hypertension, pulmonary hypertension, and CKD.
- Develop and implement clinical development strategies and trial designs; work with preclinical teams to progress molecules to first-in-human trials.
- Supervise global clinical trial execution, adverse event reporting, protocol and regulatory submission reviews, and data dissemination.
- Lead interactions with regulatory bodies worldwide and engage external medical experts to support development and trial execution.
- Ensure activities comply with applicable regulations, GCPs, Lilly policies, and Principles of Medical Research.
- Collaborate with cross-functional teams (Preclinical, Clinical Pharmacology, Health Outcomes, New Product Planning) on launch labels, value propositions, and clinical plans.
- Support medical strategies for brand commercialization and address scientific information needs of development customers (payers, patients, providers).
- Contribute to data analysis, publications, presentations, and scientific dissemination; maintain relationships with external experts and professional societies.
- Support regulatory activities globally, including regulatory documents, INDs, and FDA/EMEA interactions as needed.
- Contribute to budget management and professional development; model leadership and act as an ambassador for the Lilly Brand.
Qualifications
- Medical Doctor or Doctor of Osteopathy; board eligible or certified in appropriate specialty/subspecialty; in the US, board eligible/certified required.
- Five years of experience in clinical research/drug development with large global trials; academic or industry background acceptable.
- Ability to lead and manage groups of professionals; strong administrative, communication, and negotiation skills.
Skills
- Clinical planning and strategic development
- Clinical research design, execution, and safety monitoring
- Regulatory affairs and interactions with global health authorities
- Data analysis, scientific dissemination, and publications
- Cross-functional collaboration and stakeholder management
Education
- Medical degree (MD or DO). US board eligibility/certification or equivalent for non-US candidates as applicable.
Additional Requirements
- Authorized to work in the United States; visa sponsorship may not be provided.
- Ability to travel as required for role responsibilities.